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PSMA-PET/CT to Assess the Expression of Specific Membrane Antigen (PSMA) in Patients With Progressive Triple-negative Breast Cancer.
RECRUITINGPhase 2Sponsored by Jules Bordet Institute
Actively Recruiting
PhasePhase 2
SponsorJules Bordet Institute
Started2022-05-30
Est. completion2025-06-02
Eligibility
Age18 Years+
SexFEMALE
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT06059469
Summary
This is a descriptive, prospective, single centre study. This study will assess PSMA expression via the uptake of radiolabelled PSMA-ligand using PET/CT imaging in mTNBC lesions pre-identified on 18F-FDG PET/CT in order to evaluate the feasibility of molecular radionuclide therapy in refractory mTNBC using the Lutetium-177 radiolabelled PSMA.
Eligibility
Age: 18 Years+Sex: FEMALEHealthy volunteers accepted
Inclusion Criteria: * Written informed consent in accordance with institutional guidelines and obtained prior to any study procedure * Women with ≥ 18 years-old * Eastern Cooperative Oncology Group Performance Status of 0 to 2 * Confirmed diagnosis of progressive metastatic TNBC and presenting measurable disease on 18F-FDG PET/CT (performed within 2 weeks) or Brain MRI in case of progressive brain metastases (performed within 4 weeks) prior to PSMA PET/CT. * Radiolabelled PSMA PET/CT has to be performed before the next treatment line initiation Exclusion Criteria: * Pregnant or lactating patients * Other active neoplastic disease * Treatment by another molecule that is the object of investigation within 30 days * Skin only metastatic disease * Patients with a significant medical, neuro-psychiatric, or surgical condition, which, in the investigator's opinion, may interfere with completion of the study
Conditions3
Breast CancerCancerTNBC - Triple-Negative Breast Cancer
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Actively Recruiting
PhasePhase 2
SponsorJules Bordet Institute
Started2022-05-30
Est. completion2025-06-02
Eligibility
Age18 Years+
SexFEMALE
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT06059469